Chicago Tribune - October 30, 2008
Bruce Japsen, bjapsen@tribune.com

A new study this week shows Johnson & Johnson's protease inhibitor Prezista is "non-inferior" to Abbott's Kaletra.

There are about 10 protease inhibitors on the U.S. market, including about a half-dozen newer, next-generation drugs such as Prezista, which are considered more tolerable to AIDS patients. Although Kaletra's sales were up worldwide, they were down 6.2 percent, to $361 million, in the U.S. in the first nine months of the year, according to Abbott's earnings report this month.

Protease inhibitors are drugs that bind to and block a key enzyme vital to HIV's growth, keeping it undetectable in human blood for longer periods of time. Kaletra, like other protease inhibitors, is typically taken with two other drugs known as nucleoside reverse transcriptase inhibitors to make the so-called AIDS cocktails that are common in treating the virus.

In the head-to-head study of 689 patients studied for 96 weeks, 79 percent of patients taking Prezista had undetectable levels of HIV, compared with 71 percent in the Kaletra group. The study, funded by Tibotec, a Johnson & Johnson company, was presented this week at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C.

Doctors point out that Prezista needs Norvir, Abbott's older protease inhibitor, as a booster to work as well as Kaletra. Patients, these doctors say, like the convenience of taking Kaletra, which cuts down the number of pills to take because it also contains Norvir.

Abbott said Kaletra has a longer track record of success than Prezista, approved two years ago by the Food and Drug Administration.

"It is also important to remember that HIV patients will need to be on therapy for decades," Abbott spokeswoman Melissa Brotz said. "Results from 48-week or 96-week studies do not necessarily provide enough information for the long term."

Kaletra sales continue to grow worldwide to fight HIV. Outside the U.S., Kaletra sales were up 29.2 percent to $734 million for the first nine months of the year.

Abbott has launched various formulations of the drug such as a lower-strength tablet for children. In developing countries, Abbott has expanded its market share because its dosage of Kaletra does not require refrigeration and can be taken with or without a meal, Abbott said.

Hear Bruce Japsen on WGN-AM 720 Mondays at 12:49 p.m. and 11:15 p.m. and Sundays at 7:35 a.m.

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